9 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader
FDA 510(k)
FDA Class 2
·General Hospital
QUICKCAT EXTRACTION CATHETER, MODEL 60090-01
FDA 510(k)
FDA Class 2
·Cardiovascular
INVIVO DENTAL
FDA 510(k)
FDA Class 2
·Radiology
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·March 21, 2018
THUNDERBEAT 5MM, 20CM INLINE GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·October 10, 2014
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·June 17, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011
3 ML BD LUER-LOK LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·April 17, 2019
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
FDA Enforcement
Class II
·Ongoing·Cook Vandergrift, Inc.·September 13, 2023